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Feasibility Study of Transcutaneous Tibial Nerve Stimulation for Urinary Symptoms in People With Multiple Sclerosis

NCT04528784 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2021-04-28

No results posted yet for this study

Summary

Neurogenic lower urinary tract dysfunction is common among people with Multiple sclerosis with a pooled prevalence of 68.41% using self-report measures and 63.95% using urodynamic studies. Transcutaneous Tibial Nerve Stimulation (TTNS) is a non-invasive treatment option to manage bladder storage symptoms, however, the potential efficacy of TTNS among people with multiple sclerosis is based on a small number of studies with the absence of high-quality evidence relating to efficacy, and lack of clarity of the optimal electrical stimulation parameters and frequency, duration and number of treatment sessions. The feasibility and acceptability of TTNS to manage storage bladder symptoms using Transcutaneous Electrical Nerve Stimulation (TENS) needs to be established before proceeding with a definitive randomised trial. This study aims to assess whether TTNS is feasible and acceptable as a treatment for bladder storage symptoms in people with MS

Conditions

  • Bladder Dysfunction
  • Neurogenic Bladder Dysfunction
  • Urinary Incontinence
  • Urinary Bladder, Overactive
  • Urinary Incontinence, Urge
  • Nocturia
  • Urinary Frequency More Than Once at Night
  • Lower Urinary Tract Symptoms
  • Multiple Sclerosis
  • Urinary Bladder, Neurogenic

Interventions

DEVICE

Transcutaneous tibial nerve stimulation

Transcutaneous tibial nerve stimulation is a non-invasive electrical stimulation of the posterior tibial nerve, a branch of the sciatic nerve via sacral plexus. In our study the tibial nerve will be stimulated using Transcutaneous Electrical Nerve Stimulation (TENS) unit with two surface adhesive electrodes. The anode will be positioned between 5-10 cm above medial malleolus and posterior to the edge of the tibia and the cathode will be positioned distally on arch of the foot .

Sponsors & Collaborators

  • University of Limerick

    lead OTHER

Principal Investigators

  • Katie Robinson, PhD · University of Limerick

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-14
Primary Completion
2021-03-12
Completion
2021-03-12

Countries

  • Ireland

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04528784 on ClinicalTrials.gov